NCI Community Oncology Research Program - Protocol Summary
CTSU Alliance N1048 - "PROSPECT: A Phase II/III Trial of Neoadjuvant FOLFOX, with Selective Use of Combined Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision"
The summary below serves as a brief review of the treatment plan and eligibility for the protocol.
This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
Please follow the "Full Protocol" link or contact NCORP-KC for complete protocol information.
GI Clinical Trial
CANCER TYPE: Rectal
RESEARCH BASE: CTSU Alliance N1048
HIPPA FORM: DOWNLOAD HIPPA FORM
Consent Form: VIEW CONSENT FORM
RECTAL, adenocarcinoma, T2N1 T3N0 T3N1, candidate for sphincter-sparing resection prior to neo-adjuv therapy; Neo-adjuv FOLFOX + possible Combined Modality ChemoRT vs Combined Modality ChemoRT (both arms Low Anterior Resection [LAR] w/Total Mesorectal Excision [TME]). Credentialing required for 1) IMRT or 3D-CRT, & 2) staff member for PRO-CTCAE. DCP-001 Eligible
NOTES: 1) IMRT or 3D CRT is allowed. See §7.3.2 for credentialing requirements.
2) >1 site member must be credentialed to perform Pt-Reported Outcomes Versions of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Asmt. See §4.4.1 for
3) QOL is closed effective 2/1/2016
Treatment Plan (Supplied Drug: None)
Group 1 (FOLFOX x 6 Cycles; Cycle = 14 Days)*
Restaging of Prim Tumor
If Regression <20% OR any Progression ---> 5FUCMT ---> Low Anterior Resection w/Total Mesorectal Excision (LAR w/TME)
If No Progression AND Regression >20% ---> LAR w/TME
If margins of surgical resection are:
Negative R0 ---> Chemo suggested (FOLFOX x 6 cycles - regimen choice optional)
Positive R1 & R2 ---> Chemo suggested (5FUCMT and FOLFOX x 4 cycles. If pt already received 5FUCMT, tx is at investigator's discretion.)
Group 2 (5FUCMT; Duration = 5.5 Wks)**
Chemo suggested (FOLFOX x 8 cycles - regimen choice optional)
Oxaliplatin: 85mg/m2, IV over 2 hrs, Day 1
Leucovorin: 400mg/m2 bolus, IV over 2 hrs, Day 1
5FU: 400mg/m2 bolus over 5-15 mins then 2400mg/m2 CI over 46-48 hrs total dose, IV, Day 1 (bolus) Days 1-2 (CI)
5FU: 225mg/m2/day, CI concurrent w/RT (continuous IV 5-7 days per wk during RT)
Capecitabine: 825mg/m2, BID, PO concurrent w/RT (5 days/wk on days of planned RT)
RT: IMRT or 3D CRT - see §7.3.
- Age >18 at dx.
- Dx of rectal adenocarcinoma.
- Radiographically meas or clinically evaluable disease per §11.0.
- ECOG perf status 0-2.
- For this pt, standard tx in the absence of a clinical trial would be combined modality neoadjuv chemoRT followed by curative intent surgical resection.
- Candidate for sphincter-sparing surgical resection prior to initiation of neoadjuv therapy (prim surgeon's opinion).
- Clinical stage T2N1, T3N0, or T3N1. N2 disease estimated as >4 lymph nodes >10mm. Clinical staging based on: PE by prim surgeon, CT or PET/CT chest/abdomen/pelvis & either pelvic MRI or ERUS. If pelvic MRI performed, it is allowed to do CT chest/abdomen, omitting pelvis.
- Within 28 days pre-regist: ANC >1500/mm3; platelets >100,000/mm3; Hgb >8.0g/dL; total bili <1.5x ULN; SGOT & SGPT each <3x ULN; creat <1.5x ULN.
- Negative pregnancy test <7 days pre-regist (if applicable).
- Pts of reproductive potential must use effective contraception.
- Willing to return to study site for all asmts.
- No pts needing abdominoperineal at baseline.
- No tumor adherent to or invading mesorectal fascia on imaging, so that surgeon is unable to perform R0 resection. See §7.4.2 for details.
- No tumor causing symptomatic bowel obstruction. Temporary diverting ostomy is allowed.
- No chemo w/i 5 yrs pre-regist. Hormonal therapy allowed if disease-free >5 yrs.
- No prior pelvic RT.
- No other invasive malignancy <5 yrs pre-regist, except for colonic polyps, non-melanoma skin cancer, or cervical carcinoma in situ.
- No pregnant or nursing women.
- No co-morbid illness or other concurrent disease to preclude study completion or pt safety (opinion of person obtaining informed consent).
- PRE-STUDY REQUIREMENTS:
- H&P, pulse, BP, temp, ECOG perf status*
- Wt, ht**
- Hgb, platelets, ANC*
- SGOT, SGPT, total bili, creat*
- Research blood sample**#
- Pregnancy test (if applicable, w/i 7 days pre-regist)
- Rectal exam and proctoscopy (ideally by prim surgeon)***
- Rectal tumor tissue bx##***
- Path confirmation of rectal adenocarcinoma***
- MRI (preferred) or ERUS pelvis (use same method throughout study)*
- CT chest (contrast optional)*
- CT abdomen w/contrast*
- CT pelvis w/contrast (optional if pelvic MRI performed)*
- Pt-completed PRO-CTCAE (by computer or phone interactive voice response system; staff must be credentialed to train pt on system)**
- QOL asmt**
- Signed informed consent.
* <28 days pre-regist
** Baseline (b/f start of tx)
*** <60 days pre-regist OR post-regist but b/f start of tx
# 10mL red/grey or gold-top SST for immunology studies & 10mL purple-top EDTA for genotyping. Ship same day as drawn to Alliance Biorepository at Ohio State Univ. w/cool pack. Send M-F only via overnight delivery.
## Research-funded. Tumor block from proctoscopic bx OR outside tissue specimen. See §4.1 (note #7) & §14.0.