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Rectal CancerPhase 2/3FOWARCNCT01211210

Neoadjuvant FOLFOX6 Chemotherapy With or Without Radiation in Rectal Cancer

A Phase 2/3 study testing fluorouracil and fluorouracil, oxaliplatin in people with Rectal Cancer, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Preoperative 5-Fu based chemoradiation has become standard treatment for stage 2/3 rectal cancer. However whether these patients, especially T3N0-1M0 patients, really need radiation for local control after total mesentery excision being applied in routine practice is still unknown. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Rectal Cancer
What is being tested?
fluorouracil and fluorouracil, oxaliplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
495 participants
Where
1 siteChina
Study dates
Jun 2010to Jun 2020
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of adenocarcinoma of the rectum
  • Age: 18-75 years old
  • Stage of the primary tumor may be determined by ultrasound or MRI
  • Stage II (T_3-4, N_0 [N_0 is defined as all imaged lymph nodes < 1.0 cm]) OR stage III (T_1-4, N_1-2 [with the definition of a clinically positive lymph node being any node ≥ 1.0 cm]
  • Tumor palpable by digital rectal exam OR accessible by proctoscope or sigmoidoscope
  • Distal border of the tumor must be located < 12 cm from the anal verge
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  • Tumor amenable to curative resection
  • 15 days prior recruit, meet the following criteria: Hematopoietic
  • Absolute neutrophil count ≥ 1,200/mm^3
  • Platelet count ≥ 100,000/mm^3 Hepatic
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2 times ULN
  • AST ≤ 2 times ULN*
  • No hepatic disease that would preclude study treatment or follow-up
  • No uncontrolled coagulopathy Renal
  • Creatinine clearance > 50 mL/min
  • No renal disease that would preclude study treatment or follow-up
  • ECOG status: 0～1

Who cannot join

  • Hypersensitivity to fluorouracil, or oxaliplatin
  • No More than 4 weeks since prior participation in any investigational drug study
  • More than 4 weeks since prior participation in any investigational drug study
  • Clear indication of involvement of the pelvic side walls by imaging
  • With distant metastasis
  • History of invasive rectal malignancy, regardless of disease-free interval
Show all 14Show fewer
  • Fertile patients must use effective contraception
  • Uncontrolled hypertension
  • Cardiovascular disease that would preclude study treatment or follow-up
  • Lack of upper gastrointestinal tract integrity or malabsorption syndrome，active upper gastrointestinal tract bleeding
  • Synchronous colon cancer
  • Pregnant or nursing, Fertile patients do not use effective contraception
  • Other malignancy within the past 5 years except effectively treated squamous cell or basal cell skin cancer, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum
  • No psychiatric or addictive disorders, or other conditions that, in the opinion of the investigator, would preclude study participation

Trial locations and contacts

1 site in 1 country.

China1 site

  • Gastrointestinal Hospital, Sun Yatsen University

    Guangzhou, Guangdong, 510655

Other trials in China

About this study

Official title: A Phase II/III Randomized Controlled Study of Neoadjuvant FOLFOX6 Treatment With or Without Radiation Compared to 5-Fu Based Chemoradiation in Treating Patients With Resectable Rectal Cancer

RATIONALE: Preoperative 5-Fu based chemoradiation has become standard treatment for stage 2/3 rectal cancer. However whether these patients, especially T3N0-1M0 patients, really need radiation for local control after total mesentery excision being applied in routine practice is still unknown. And whether new drugs adding in can achieve better local and distant control is worth investigating.

PURPOSE: This randomized phase II trial is studying 5Fu based radiation therapy or FOLFOX based radiation or FOLFOX alone, comparing them to see how well they work when given before surgery in treating patients with intermediate risk resectable rectal cancer. It is not yet known whether 5-Fu based or FOLFOX based radiation therapy or even FOLFOX alone is more effective in treating rectal cancer.

Read the detailed description

OBJECTIVES:

Primary Compare the objective response rate and the rate of local-regional relapse in patients with resectable rectal cancer treated with either 5-Fu or FOLFOX based chemoradiotherapy or FOLFOX alone without radiation.

Secondary

  1. Compare the rate of pathologic complete response in patients treated with these regimens.
  2. Compare the local recurrence rate

2.Determine the increase in the number of patients who are able to undergo sphincter-saving surgery after treatment with these regimens.

3.Correlate genetic patterns and the presence or absence of specific tissue biomarkers with response and prognosis in patients treated with these regimens.

4.Compare preoperative quality of life (QOL) of patients treated with oral capecitabine versus continuous infusion with fluorouracil. pelvic auto-nerve function 5.Determine the impact of oxaliplatin on neurotoxicity in patients treated with these regimens.

6.Compare the toxic effects of these regimens in these patients. 7.Compare the convenience of care in patients treated with these regimens. 8.Determine the impact of the type of surgical management on QOL at 1 year postoperatively in these patients.

OUTLINE: This is a randomized, multi-center study. Patients are stratified according to participating center, gender, clinical tumor stage (stage II vs. stage III), and surgical intent (sphincter saving vs. non-sphincter saving). Patients are randomized to 1 of 4 treatment arms.

  • Arm A: Patients receive fluorouracil IV continuously and undergo radiotherapy once daily 5 days a week for 5-6 weeks.
  • Arm B: Patients receive FOLFOX for 4 cycles and undergo radiotherapy as in arm I from the second cycle of FOLFOX.
  • Arm C: Patients receive FOLFOX for 4 cycles Within 4-6 weeks after the completion of chemo radiotherapy, patients with responding or stable disease undergo surgery. Patients with progressive disease are treated at the discretion of the investigator and continue to be followed. Patients with progressive disease in arm III should received radiation.

Quality of life is assessed at baseline, at completion of chemo radiotherapy, and at 1 year after surgery.

After completion of study treatment, patients are followed every 3 months for 2 years, and then every 6 months for 3years.

PROJECTED ACCRUAL: A total of 495 patients will be accrued for this study within 5 years.

Eligibility Ages Eligible for Study: 18-75 Years old Genders Eligible for Study: Both Accepts Healthy Volunteers: No

Conditions
Rectal Cancer
Being tested
fluorouracil, fluorouracil, oxaliplatin
Keywords
rectal cancer, neoadjuvant therapy, oxaliplatin, radiation
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fluorouracilDrug

    Also called 5-Fu, RT

    Drug: fluorouracil Given IV continuously Radiation: radiation therapy Given 5 days a week for 5-6 weeks

  • fluorouracil, oxaliplatinDrug

    Also called 5-Fu, Oxaliplatin, RT

    Drug: fluorouracil Given IV continuously Drug: oxaliplatin Given IV Radiation: radiation therapy Given 5 days a week for 5-6 weeks

  • fluorouracil, oxaliplatinDrug

    Also called 5-Fu, Oxaliplatin

    Drug: fluorouracil Given IV continuously Drug: oxaliplatin Given IV

Study groups in NCT01211210
Study groupRoleWhat they receive
A: 5Fu with RadiationActive comparatorPatients receive fluorouracil IV continuously and undergo radiotherapy once daily 5 days a week for 5-6 weeks.
Receives: Drug: fluorouracil
B: FOLFOX with radiationExperimentalPatients receive FOLFOX for 5 cycles and undergo radiotherapy as in arm I from the second cycle of FOLFOX
Receives: Drug: fluorouracil, oxaliplatin
C: FOLFOX aloneExperimentalPatients receive FOLFOX for 4 cycles
Receives: Drug: fluorouracil, oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 3-year disease free survival

    Compare 3-year disease free survival in patients with resectable rectal cancer treated with either 5-Fu or FOLFOX based chemoradiotherapy or FOLFOX alone without radiation.

    Measured: 2 years

Secondary outcomes (7)

  1. pathologic complete response rate

    Measured: 1 years

  2. local recurrence rate

    Measured: 3 years

  3. overall survival

    Measured: 5 years

  4. sphincter-saving surgery rate

    Measured: 1 year

  5. R0 resection rate

    Measured: 1 year

  6. predictive biomarkers

    Measured: 3 year

  7. quality of life

    Measured: 3 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionJun 2017 (estimated)
  4. Study completionJun 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
495 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01211210
Sponsor's protocol ID
GIHSYSU01
Acronym
FOWARC
Status last verified
Nov 2013
First submitted
28 Sep 2010
Last updated
22 May 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Zhang T, Shi L, Jian L, Jiang J, Qiu Y, Xie F, Zhang J, Peng H, Zhong L, Chen Y, Zhong Y, Deng Y; FOWARC Group. Clinical Benefit and Cost-Effectiveness of FOLFOX Versus LCCRT in Neoadjuvant Treatment for Patients with Locally Advanced Rectal Cancer: An Economic Analysis of the FOWARC and PROSPECT Trial. Ann Surg Oncol. 2026 May;33(5):3814-3826. doi: 10.1245/s10434-025-18802-8. Epub 2025 Dec 11.

    PubMed 41379261

  • Wan H, Weng J, Cai J, Chen Z, Li P, Han J, Li Z, Wan Z, Yuan Z, Gan Y, Huang M, Li X, Li T, Liu X, Wang X, Yu H, Liu B, Lin J, Luo Y. Nodal Downstaging in Patients With Rectal Cancer: Survival Is Promising if YpN0 Is Achieved. Dis Colon Rectum. 2025 Oct 1;68(10):1162-1171. doi: 10.1097/DCR.0000000000003846. Epub 2025 Jul 8.

    PubMed 40626521

  • Shi L, Zhang J, Deng Y. Associations of pretreatment emotional distress with adherence to therapy for patients with locally advanced rectal cancer: a post hoc analysis of the Chinese FOWARC phase 3 randomized clinical trial. BMC Med. 2025 May 21;23(1):293. doi: 10.1186/s12916-025-04128-5.

    PubMed 40399932

  • Zhang J, Chi P, Shi L, Cui L, Gao J, Li W, Wei H, Cheng L, Huang Z, Cai G, Zhao R, Huang Z, Zhou H, Wei Y, Zhang H, Zheng J, Huang Y, Cai Y, Zhou Z, Kang L, Huang M, Wu X, Peng J, Ren D, Lan P, Wang J, Deng Y. Neoadjuvant Modified Infusional Fluorouracil, Leucovorin, and Oxaliplatin With or Without Radiation Versus Fluorouracil Plus Radiation for Locally Advanced Rectal Cancer: Updated Results of the FOWARC Study After a Median Follow-Up of 10 Years. J Clin Oncol. 2025 Feb 20;43(6):633-640. doi: 10.1200/JCO-24-01676. Epub 2024 Dec 13.

    PubMed 39671537

  • Li L, Xu B, Zhuang Z, Li J, Hu Y, Yang H, Wang X, Lin J, Zhou R, Chen W, Ran D, Huang M, Wang D, Luo Y, Yu H. Accurate tumor segmentation and treatment outcome prediction with DeepTOP. Radiother Oncol. 2023 Jun;183:109550. doi: 10.1016/j.radonc.2023.109550. Epub 2023 Feb 21.

    PubMed 36813177

  • Xie Y, Lin J, Wang X, Wang P, Zhuang Z, Zou Q, Cai D, Huang Z, Bai L, Tang G, Huang M, Wang J, Yu H, Luo Y. The Addition of Preoperative Radiation Is Insufficient for Lateral Pelvic Control in a Subgroup of Patients With Low Locally Advanced Rectal Cancer: A Post Hoc Study of a Randomized Controlled Trial. Dis Colon Rectum. 2021 Nov 1;64(11):1321-1330. doi: 10.1097/DCR.0000000000001935.

    PubMed 33990500

  • Deng Y, Chi P, Lan P, Wang L, Chen W, Cui L, Chen D, Cao J, Wei H, Peng X, Huang Z, Cai G, Zhao R, Huang Z, Xu L, Zhou H, Wei Y, Zhang H, Zheng J, Huang Y, Zhou Z, Cai Y, Kang L, Huang M, Wu X, Peng J, Ren D, Wang J. Neoadjuvant Modified FOLFOX6 With or Without Radiation Versus Fluorouracil Plus Radiation for Locally Advanced Rectal Cancer: Final Results of the Chinese FOWARC Trial. J Clin Oncol. 2019 Dec 1;37(34):3223-3233. doi: 10.1200/JCO.18.02309. Epub 2019 Sep 26.

    PubMed 31557064

  • Hu H, Huang J, Lan P, Wang L, Huang M, Wang J, Deng Y. CEA clearance pattern as a predictor of tumor response to neoadjuvant treatment in rectal cancer: a post-hoc analysis of FOWARC trial. BMC Cancer. 2018 Nov 20;18(1):1145. doi: 10.1186/s12885-018-4997-y.

    PubMed 30458734

  • Qin Q, Ma T, Deng Y, Zheng J, Zhou Z, Wang H, Wang L, Wang J. Impact of Preoperative Radiotherapy on Anastomotic Leakage and Stenosis After Rectal Cancer Resection: Post Hoc Analysis of a Randomized Controlled Trial. Dis Colon Rectum. 2016 Oct;59(10):934-42. doi: 10.1097/DCR.0000000000000665.

    PubMed 27602924

  • Deng Y, Chi P, Lan P, Wang L, Chen W, Cui L, Chen D, Cao J, Wei H, Peng X, Huang Z, Cai G, Zhao R, Huang Z, Xu L, Zhou H, Wei Y, Zhang H, Zheng J, Huang Y, Zhou Z, Cai Y, Kang L, Huang M, Peng J, Ren D, Wang J. Modified FOLFOX6 With or Without Radiation Versus Fluorouracil and Leucovorin With Radiation in Neoadjuvant Treatment of Locally Advanced Rectal Cancer: Initial Results of the Chinese FOWARC Multicenter, Open-Label, Randomized Three-Arm Phase III Trial. J Clin Oncol. 2016 Sep 20;34(27):3300-7. doi: 10.1200/JCO.2016.66.6198. Epub 2016 Aug 1.

    PubMed 27480145

  • Huang M, Lin J, Yu X, Chen S, Kang L, Deng Y, Zheng J, Luo Y, Wang L, Lan P, Wang J. Erectile and urinary function in men with rectal cancer treated by neoadjuvant chemoradiotherapy and neoadjuvant chemotherapy alone: a randomized trial report. Int J Colorectal Dis. 2016 Jul;31(7):1349-57. doi: 10.1007/s00384-016-2605-7. Epub 2016 Jun 6.

    PubMed 27270480

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing fluorouracil and fluorouracil, oxaliplatin in people with Rectal Cancer, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3-year disease free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01211210, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2015.

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