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Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer

ConditionRectal Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCanadian Cancer Trials Group

About this trial

This study is being done to answer the following questions: Is the chance of rectal cancer responding the same if chemotherapy alone is given before limited surgery compared to chemotherapy and radiation therapy given together before limited surgery? If radiation therapy is not given, is quality of life better?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed invasive, well-moderately differentiated rectal adenocarcinoma, mismatch repair proficient.

MRI stage cT1 not eligible for transanal surgery or cT2-T3ab*. * T3a: <1mm depth invasion, T3b: 1-5mm depth of invasion.

cN0 stage based on pelvic MRI - including absence of radiographic evidence of mesorectal nodal metastasis, tumour deposits or extramural venous invasion (EMVI).

M0 stage based on no evidence of metastatic disease by CT imaging of chest, abdomen and pelvis.

Disqualifiers

Pathologic high-risk factors on diagnostic biopsy: high histologic grade (poorly differentiated), mucinous or signet ring histology.

Patients with visible pelvic sidewall nodes on MRI.

Patients with unequivocal determination of nodal disease that, in the opinion of the investigator, would prohibit protocol therapy administration.

Previous pelvic radiation for any reason, including brachytherapy alone.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Leucovorin

    Drug

    400 mg/m2

  • Oxaliplatin

    Drug

    85 mg/m2 or 130 mg/m2 on day 1

  • Fluoruracil

    Drug

    bolus fluoruracil (optional) 400 mg, infusional fluorouracil 2,400 mg/m2

  • Capecitabine

    Drug

    1,000 mg/m2 twice daily for 14 days

  • Radiation

    Radiation

    54 Gy (27-30 fractions)

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: FOLFOX OR CAPOXActive comparator 4 interventions
Group B: ChemoRTActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Clinical response rate upon re-staging

Time frame
6 years
2

Quality of Life defined using the LARS score

Time frame
6 years

Secondary outcomes

1

Total Mesorectal Excision (TME) Free Survival

Defined as time from randomization to the time of TME attempt or performance, local recurrence after complete clinical response (cCR), or death from any cause

Time frame
6 years
2

Disease Free Survival

Defined as time from randomization to local recurrence/regrowth after cCR that cannot be salvaged with an R0 TM, M1 recurrence, or death

Time frame
6 years
3

Overall Survival

Among patients treated with induction chemotherapy versus chemoradiotherapy

Time frame
6 years
4

Rate of downstaging to ypTO/1N0/X

Time frame
6 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Canadian Cancer Trials Group

Lead sponsor

Alliance for Clinical Trials in Oncology

Collaborator

ECOG-ACRIN Cancer Research Group

Collaborator

NRG Oncology

Collaborator

SWOG Cancer Research Network

Collaborator

Source ClinicalTrials.gov
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