Adult Clinical Trials:HEAD AND NECK

RTOG 0232: PROSTATE

A Phase III Study Comparing Combined External Beam Radiation And Transperineal Interstitial Permanent Brachytherapy With Brachytherapy Alone For Selected Patients With Intermediate Risk Prostatic Carcinoma

• Histologically confirmed, locally confined adenocarcinoma of the prostate.
• Clinical stages T1c-T2b.
• Zubrod 0-1.
• Combined Gleason 7 if PSA < 10, combined Gleason < 7 if PSA 10-20; PSA must be < 20ng/mL, before hormone therapy, if given (if Gleason 2-6, then PSA must be > 10 ng/mL; Prostate volume by TRUS < 60 cc.
• No prior chemotherapy, pelvic radiation, no prior TURP, cryosurgery, TUNA, TUMT or radical surgery for carcinoma of the prostate.
• No previous hormonal therapy beginning < 2 months or > 6 months prior to registration
• No distant metastases, no clinically or pathologically involved lymph nodes.
• No significant obstructive symptoms.
• AUA must be < 15 (alpha blockers allowed).
• No major medical or psychiatric illness.

Treatment

Arm 1: 45 Gy EBRT, partial pelvis (1.8 Gy/fraction M-F for 5 weeks) followed 2-4 weeks later by Pd-103 (100 Gy) or I-125 (110 Gy)*
Arm 2: Pd-103 (125 Gy) or I-125 (145 Gy)*
*Protocol treatment must begin within 4 weeks after study entry.

RTOG 0521:  PROSTATE

A Phase III Protocol of Androgen Suppression (AS) And 3DCRT/IMRT Vs AS and 3DCRT/IMRT Followed by Chemotherapy With Docetaxel and Prednisone for Localized, High-Risk Prostate Cancer
Histologically confirmed (within 180 days prior to registration) prostate cancer at high-risk for recurrence as determined by one of the following combinations:

• Clinically negative lymph nodes as established by imaging (pelvic CT or pelvic MR), nodal sampling, or dissection within 90 days prior to registration

Treatment

Arm 1
AS (LHRH agonist and oral antiandrogen) x 8 weeks followed by RT to 72.0-75.6 Gy with concurrent AS (LHRH agonist and oral antiandrogen). LHRH will continue for a total of 24 months from initiation of any treatment. Oral antiandrogen will be discontinued at the end of radiotherapy.

Arm 2
AS (LHRH agonist and oral antiandrogen) x 8 weeks followed by RT to 72.0-75.6 Gy with concurrent AS (LHRH agonist and oral antiandrogen). LHRH will continue for a total of 24 months from initiation of any treatment. Oral antiandrogen will be discontinued at the end of RT.
PLUS
Six cycles of docetaxel and prednisone delivered concurrently with androgen suppression beginning 28 days after completion of RT:
Docetaxel i.v. over 1 hour (on day 1 of each cycle) q 21 days
(Premedication for docetaxel with dexamethasone is required)
AND
Prednisone p.o. daily until day 21 of the last cycle of chemotherapy.

RTOG 0534: PROSTATE

Phase III Trial Of Short Term Androgen Deprivation With Pelvic Lymph Node Or Prostate Bed Only Radiotherapy (SPORT) In Prostate Cancer Patients With A Rising PSA After Radical ProstatectomyTERMINDED IN ALL ORDERS GIVEN

• Adenocarcinoma of the prostate treated primarily with radical prostatectomy, pathologically proven to be lymph node negative by pelvic lymphadenectomy (N0) or lymph node status pathologically unknown (undissected pelvic lymph nodes [Nx]), i.e., lymph node dissection is not required;
• Any type of radical prostatectomy will be permitted. If performed, the number of lymph nodes removed per side of the pelvis and the extent of the pelvic lymph node dissection (obturator vs. extended lymph node dissection) should be noted;
• Post-radical prostatectomy entry PSA of > 0.2 and < 2.0 ng/mL at least 6 weeks after prostatectomy and within 30 days of registration;
• One of the following pathologic classifications: T3N0/Nx disease or T2N0/Nx disease with positive prostatectomy margin and/or positive prostatic fossa or urethral-vesical anastomosis biopsies;
•  Prostatectomy Gleason score of 8 or less; PSA doubling time of > 6 months prior to registration;
•  Zubrod Performance Status of 0-1;
• Digital rectal exam within 30 days prior to registration; No distant metastases, based upon the minimum diagnostic workup defined in the protocol;
•  AST or ALT < 2 x the upper limit of normal within 90 days prior to registration;
• Serum total testosterone within 90 days prior to registration;
• No palpable prostatic fossa abnormality/mass suggestive of recurrence, unless shown by biopsy under ultrasound guidance not to contain cancer;
• N1 patients are ineligible, as are those with pelvic lymph node enlargement > 1.5 cm in greatest dimension by CT scan or MRI of the pelvis, unless the enlarged lymph node is sampled and is negative;
•  No androgen deprivation therapy started prior to prostatectomy for > 6 months duration;
• No androgen deprivation therapy started after prostatectomy and prior to registration;
• No prior pelvic radiotherapy;
• No prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 5 years (for example, carcinoma in situ of the oral cavity is permissible);
•  Patients with PSA doubling time of < 6 months are ineligible.

 

Treatment

Arm 1: PBRT Alone*
PBRT 64.8-70.2 Gy

Arm 2: PBRT + NC-STAD
PBRT 64.8-70.2 Gy + NC-STAD for 4-6 months, beginning 2 months before RT

Arm 3: PLNRT + PBRT + NC-STAD
PLNRT to 45 Gy and PBRT to 64.8-70.2 Gy, NC-STAD for 4-6 months, beginning 2 months before RT

*SV = seminal vesicle; RT = radiotherapy; PBRT = prostate bed RT; PLNRT = pelvic lymph node RT; NC-STAD = neoadjuvant and concurrent short term androgen deprivation    CERTIFICATE

 

RTOG 0612: PROSTATE

Investigating Markers of Radiation Outcome in Patients With Intermediate-Risk Prostate Cancer Using DNA Microarray Analysis: An RTOG Pilot Study

• Patient must be eligible for RTOG 0232.
• Patient must be enrolled on RTOG 0232.
• Submission of the paraffin tissue block from initial diagnosis.
•  Submission of the biopsy specimen that contains frozen tissue.
•  Patient must sign a study-specific informed consent for RTOG 0612 prior to study entry.

RTOG 0621:  PROSTATE

Adjuvant 3DCRT/IMRT in Combination with Androgen Suppression and Docetaxel for High Risk Prostate Cancer Patients Post-Prostatectomy: A Phase II Trial
Pathologically proven diagnosis of adenocarcinoma of the prostate gland at the time of prior radical prostatectomy meeting one of the following combinations:

• Pathologic Gleason > 7 and post-operative PSA nadir > 0.2 ng/ml with any pT classification;
• Pathologic Gleason > 8, post-operative PSA nadir < 0.2 ng/ml and > pT3a classification. Enrollment must occur within 1 year from radical prostatectomy.
• Study entry PSA must be obtained within 6 weeks (42 days) prior to registration.
• No lymph node or distant metastases (N0, M0), based upon the diagnostic workup specified in the protocol.
• Evaluation and approval for study participation by a medical oncologist prior to registration.
• No prior systemic chemotherapy for the study cancer. No prior androgen deprivation for treatment of prostate cancer. No prior use of hormonal agents such as finasteride or dutaseride for treatment of benign prostatic hypertrophy is allowed.

Treatment:

LHRH Agonist and Non-Steroidal Antiandrogen for 6 months

RT: 66.6 Gy/1.8 Gy/fraction, starting 8 weeks after initiation of androgen suppression

Docetaxel, starting 3-6 weeks after completion of radiation, Day 1 of each 21-day cycle x 6 cycles